Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

Normal male subjects aged 20-65 years
Normal male subjects aged 20-65 years

Exclusion Criterias

Women Smokers, HIV positive, diabetes, hepatatis C positive, subjects currently taking testosterone who are unwilling to suspend use for teh duration of the trial, subjects taking aldactone or medicines that may interfere with the protocol
Women Smokers, HIV positive, diabetes, hepatatis C positive, subjects currently taking testosterone who are unwilling to suspend use for teh duration of the trial, subjects taking aldactone or medicines that may interfere with the protocol

Summary

Conditions
Known Androgen Deficiency
Type
Observational
Design
  • Observational Model: Cohort
  • Time Perspective: Prospective

Participation Requirements

Age
Between 20 years and 65 years
Gender
Only males

Description

Testosterone is required for normal male health that is known to decline in aging or other conditions. Physiologically active testosterone, also known as "free" testosterone, is present as a small percentage of the total blood level, mostly bound to sex hormone binding globulin and albumin. Estimati...

Testosterone is required for normal male health that is known to decline in aging or other conditions. Physiologically active testosterone, also known as "free" testosterone, is present as a small percentage of the total blood level, mostly bound to sex hormone binding globulin and albumin. Estimation of serum free testosterone is difficult and costly, requiring equilibrium dialysis of a serum sample. These binding proteins are not normally present in saliva. It is hypothesized that the free fraction of testosterone in blood is in equilibrium with the extravascular space, notably saliva. The sponsor proposes to test this hypothesis by sampling saliva and serum and measuring testosterone. Serum free testosterone will be measured following equilibrium dialysis. To perform this study approximately 40 eugonadal and 20 hypogonadal males will be recruited.

Inclusion Criterias

Normal male subjects aged 20-65 years
Normal male subjects aged 20-65 years

Exclusion Criterias

Women Smokers, HIV positive, diabetes, hepatatis C positive, subjects currently taking testosterone who are unwilling to suspend use for teh duration of the trial, subjects taking aldactone or medicines that may interfere with the protocol
Women Smokers, HIV positive, diabetes, hepatatis C positive, subjects currently taking testosterone who are unwilling to suspend use for teh duration of the trial, subjects taking aldactone or medicines that may interfere with the protocol

Locations

Washington, District of Columbia, 20007
Baltimore, Maryland, 21827
Washington, District of Columbia, 20007
Baltimore, Maryland, 21827

Tracking Information

NCT #
NCT01909505
Collaborators
Not Provided
Investigators
  • Principal Investigator: West T Moore, M.D. Georgetown University
  • West T Moore, M.D. Georgetown University